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| Name | Class |
|---|---|
| TC Erciyes University | OTHER |
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The objective is to determine the safety and immunogenicity of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19.
This is a double-blind, double dose, parallel, randomized vaccination study. Each subject will receive in random order a double intramuscular dose of ERUCOV-VAC 3 µg/0.5 ml Vaccine, ERUCOV-VAC 6 µg/0.5 ml Vaccine or 0.5 ml of placebo Vaccine according to a sequence determined by randomization, on Day 0 (1st vaccination) and Day 21 (2nd vaccination).In total 34 healthy subjects of both genders will be monitored for one year in total, after Day 43 the study will be unblinded and the volunteers who took placebo vaccine will be released from the study. The most important evaluation will be performed on Day 43 after the first vaccine dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose vaccine | Experimental | Type: Biological/Vaccine Name: ERUCOV-VAC 3 µg/0.5 ml Vaccine Intervention Description:Two applications on Days 0 and 21 |
|
| Medium dose vaccine | Experimental | Type: Biological/Vaccine Name: ERUCOV-VAC 6 µg/0.5 ml Vaccine Intervention Description: Two applications on Days 0 and 21 |
|
| Placebo | Placebo Comparator | Placebo Vaccine, containing 0.9 % saline Intervention Description: Two applications on Days 0 and 21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERUCOV-VAC | Biological | Vaccination on Day 0 and Day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of the COVID-19 vaccine | The number and proportion of subjects with adverse events observed until Day 43 post 1st vaccination are declared to be primary target variables. | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IgG antibody Levels | Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s). | 12 months |
| Neutralizing Antibodies Levels | Serum Neutralizing antibody levels. |
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Inclusion Criteria:
Exclusion Criteria:
Non-pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Zafer Sezer | Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP) | Kayseri | 38038 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36460536 | Result | Ozdarendeli A, Sezer Z, Pavel STI, Inal A, Yetiskin H, Kaplan B, Uygut MA, Bayram A, Mazicioglu M, Unuvar GK, Yuce ZT, Aydin G, Aslan AF, Kaya RK, Koc RC, Ates I, Kara A. Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials. Vaccine. 2023 Jan 9;41(2):380-390. doi: 10.1016/j.vaccine.2022.10.093. Epub 2022 Nov 22. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000721868 | TURKOVAC |
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| Placebo Vaccine | Other | Placebo Vaccination on Day 0 and Day 21 |
|
| 12 months |
| TNF-alpha Levels | Serum TNF-alpha levels. | 12 months |
| Interferon Levels | Serum IFN-γ levels. | 12 months |
| Interleukine Levels | Serum IL-2, -4, -5, -6 levels. | 12 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |